Zimmer Biomet Recalls ARCOS Modular Revision Hip System Femoral Stems
Zimmer Biomet is recalling 12 ARCOS Modular Revision Hip System femoral stems because they may have been mixed with Echo BI-Metric stems, potentially extending surgery time.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the stated consequence is procedural (extended surgery time) rather than direct physical injury or hospitalization, fitting the Moderate category for low-risk operational issues.
Plain-English summary
Zimmer Biomet, Inc. is recalling 12 units of the ARCOS Modular Revision Hip System, item number 11-300814, which is an orthopedic hip prosthesis femoral stem. The recall is due to a potential comingling issue where two lots of the Echo BI-Metric Hip Stem and the ARCOS Modular Revision Hip Stem may have been mixed.
The affected units are from lot 621550 and were distributed in the United States to California, Georgia, Illinois, Missouri, New York, and Virginia. The potential health consequence identified is the extension of surgery time required to find a replacement component.
Healthcare providers and patients should contact Zimmer Biomet for further instructions regarding the replacement of these components.
The recalled product
- Product
- ARCOS Modular Revision Hip System, item number 11-300814 orthopedic hip prosthesis femoral stem.
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 12
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- lot 621550 UDI (01)00880304474154(17)280206(10)621550
Distribution
Part of a larger recall action
This product is one of 2 recalled by Zimmer Biomet, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Zimmer Biomet, Inc.
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- HighZimmer Biomet Recalls Hip Prosthesis Components Due to Sterilant Biocompatibility Concerns
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Same hazard · component mixing
See all →- HighIntegra Recalls NewPort MIS System Due to Potential Component Mixing
FDA (Devices) · 2014-08-20
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